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논문 기본 정보

자료유형
학술저널
저자정보
정문구 (한국화학연구소 안전성연구부) 김종춘 (한국화학연구소 안전성연구부) 한상섭 (한국화학연구소 안전성연구부)
저널정보
한국응용약물학회 The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology 제4권 제1호
발행연도
1996.1
수록면
59 - 67 (9page)

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A new composite antibiotic, SM-101(sulbactam·metampicillin), was at dose levels of 0, 375, 750 and 1500 mg/kg/day administered intravenously to pregnant Sprague-Dawley rats during the organogenetic period. Two-third of dams per group were subjected to caesarean section on day 20 of pregnancy and the remaining 10 dams per group were allowed to deliver. Effects of test substance on dams, embryonal development of F1 fetuses, as well as growth, behaviour and mating performance of F1 offspring were examined. In dams, two deaths occurred at 375 and 1500 mg/kg, respectively. The decrease in the weight of adrenal glands of the 1500 mg/kg group was observed. The prolongation of pregnancy period was found at 1500 mg/kg. F1 fetuses showed no changes related to the treatment of SM-101. In F1 offspring, the increase in spleen weight was seen at all doses treated. No treatment-related abnormalities were observed in each treated group in terms of development, behaviour and reproductive performance. In F2 fetuses, no drug-induced abnormalities occurred at all doses. The results show that the no-effect dose levels (NOELS) for dams and Fl offspring are under 375 mg/kg/day and NOELs for F1/F2 fetuses are over 1500 mg/kg/day.

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